Soft robotic ventricular assist device with septal bracing for therapy of heart failure.

Previous soft robotic ventricular assist devices have generally targeted biventricular heart failure and have not engaged the interventricular septum that plays a critical role in blood ejection from the ventricle. We propose implantable soft robotic devices to augment cardiac function in isolated left or right heart failure by applying rhythmic loading to either ventricle. Our devices anchor to the interventricular septum and apply forces to the free wall of the ventricle to cause approximation of the septum and free wall in systole and assist with recoil in diastole. Physiological sensing of the native hemodynamics enables organ-in-the-loop control of these robotic implants for fully autonomous augmentation of heart function. The devices are implanted on the beating heart under echocardiography guidance. We demonstrate the concept on both the right and the left ventricles through in vivo studies in a porcine model. Different heart failure models were used to demonstrate device function across a spectrum of hemodynamic conditions associated with right and left heart failure. These acute in vivo studies demonstrate recovery of blood flow and pressure from the baseline heart failure conditions. Significant reductions in diastolic ventricle pressure were also observed, demonstrating improved filling of the ventricles during diastole, which enables sustainable cardiac output.